Protocol summary
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Study aim
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The aim of this study is to evaluate the efficacy of Iranian herbal remedy on spermogram parameter in men with idiopathic infertility.
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Design
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This study is a clinical trial without a control group and placebo, in the form of before_after analysis.
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Settings and conduct
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The infertile patients were referred to the Persian medicine infertility clinics in Imam Khomeini Hospital Complex with idiopathic oligo-astheno-teratozoospermia according to inclusion and exclusion criteria intake drug dose.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: 1. Men 20-45 years; 2. infertility for at least one year; 3. oligo-astheno-teratozoospermia unexplained according to WHO. Exclusion criteria: 1. The history of intake of chemotherapy, corticosteroid, anticoagulation, testosterone, and antiandrogen; 2. The incidence of severe cases of oligospermia; 3. infections, genital anatomical abnormalities, chromosomal abnormalities, history of surgery on the genital tract, and exposure to toxins; 4. Alcohol or drug abuse; 5. systemic diseases.
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Intervention groups
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The therapeutic dose is 5 g from remedy BID for 3 months, and after 3 months samples tested and new spermogram be analyzed, and the results will be compared.
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Main outcome variables
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Improving sperm volume or concentration or sperm motility or normal morphology of sperm is important.
General information
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Reason for update
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Making minor changes in some parts after the end of the trial
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2015100624377N1
Registration date:
2015-11-06, 1394/08/15
Registration timing:
registered_while_recruiting
Last update:
2023-02-14, 1401/11/25
Update count:
2
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Registration date
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2015-11-06, 1394/08/15
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Vice chancellor for research,Tehran University of Medical Sciences, Iranian Traditional Medicine fac
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Expected recruitment start date
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2015-09-23, 1394/07/01
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Expected recruitment end date
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2016-02-04, 1394/11/15
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Actual recruitment start date
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2015-09-23, 1394/07/01
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Actual recruitment end date
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2016-02-04, 1394/11/15
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Trial completion date
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2016-05-21, 1395/03/01
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Scientific title
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The efficacy of one of the Iranian Traditional Remedy(lobub morakab) in spermogram parameter in Idiopathic Male Infertility in Imam Khomeyni hospital
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Public title
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The efficacy of one of the Iranian Traditional Remedy on spermogram in infertile men
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Men 20-45 years
Infertility for at least one year
Unexplained Oligo-astheno-teratozoospermia according to WHO criteria: Sperm concentrations below 20 million per milliliter; 5. Motile sperm less than 50%; 6. The normal morphology less than 30%
Exclusion criteria:
History of taking chemotherapy, Corticosteroid, Anticoagulation, Testosterone, Antiandrogen
The incidence of severe cases of oligospermia (sperm concentration less than one million per milliliter)
Infections, genital anatomical abnormalities, chromosomal abnormalities, history of surgery on the genital tract, exposure to toxins
Alcohol or drug abuse
Systemic diseases (cancer, thyroid disease, liver and gall bladder diseases, renal failure, etc.)
The reluctance of patients to continue
Make any side effects from medication
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Age
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From 20 years old to 45 years old
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Gender
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Male
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Phase
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2-3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
43
Actual sample size reached:
43
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Randomization (investigator's opinion)
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N/A
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Single
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2015-10-11, 1394/07/19
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Ethics committee reference number
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IR.TUMS.REC.1394.847
Health conditions studied
1
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Description of health condition studied
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Infertility
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ICD-10 code
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N46
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ICD-10 code description
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Diseases of male genital organs,Male infertility,
Primary outcomes
1
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Description
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Semen volume
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Timepoint
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At the begining of the trial, 3 months after end of the drug
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Method of measurement
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Semen analysis
2
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Description
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Sperm count
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Timepoint
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At the begining of the trial, 3 months after end of the drug
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Method of measurement
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Sperm analysis
3
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Description
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Sperm motility
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Timepoint
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At the begining of the trial, 3months after end of the drug
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Method of measurement
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Semen analysis
4
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Description
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Normal morphology
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Timepoint
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At the begining of the trial, 3months after end of the dru
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Method of measurement
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Semen analysis
Secondary outcomes
1
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Description
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Fertility
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Timepoint
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After treatment
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Method of measurement
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Partner pregnancy
2
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Description
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Side effects such as itching, etc.
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Timepoint
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During the intervention
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Method of measurement
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Patient report
Intervention groups
1
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Description
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Remedy recommended 5 g, twice a day with milk for 3 months
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available